PHARMA-STATS

PHARMA-STATS 📊Biostatistics and Programming Services for Clinical Trials
🚀Training for Biostatistics When the stakes are so high, you need a high-performance partner.

PHARMA-STATS is founded by Dr Nirali Mehta in 2013 with a vision to empower a 'Single point statistical solution' to the Pharmaceutical & Research industry. She is also known as a 'Regulatory Consultant for Pharmaceutical Statistics'. She is sharing her proficiency in the pharma industry for almost two decades. We have deep intensity and intereste in applications of statistics to various research areas followed by pharmaceutical and drug development research. We have the expertise to deliver specialized drug development services and statistical solutions, designing studies in complex indications and modalities. We at PHARMA-STATS have the experts to organize your toughest challenges with confidence and accuracy. We provide valuable insight, high-quality deliverables, and unpaired patron statistical service, giving you expert guidance to identify the specialized solutions you require to enhance your molecules. Connect us on www.pharma-stats.com and let us allow you to design and execute your successive, timely deliverable statistical model. Automation in BABE Analysis: We have developed R-based AI tool for Pharmacokinetics and BABE analysis. It supports and saves major time for pharmaceuticals and CROs to execute pilot and pivotal non-CDISC statistical analysis. Educating for Biostatistics is our passion which helps statisticians as well as non-statisticians who are working in clinical research, quality assurance, formulation development, project management, regulatory affairs, practising doctors, ethics committee members, regulatory agencies, academia for clinical statistics.

Address

Ahmedabad

Opening Hours

Monday 9:30am - 5:30pm
Tuesday 9:30am - 5:30pm
Wednesday 9:30am - 5:30pm
Thursday 9:30am - 5:30pm
Friday 9:30am - 5:30pm

Telephone

917984868750

Website

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Our Story

Established in 2013, PHARMA-STATS is emerging as the fasted growing Biostatistical Training Institute and Biostatistical Consultancy Services from India. Ms. Nirali Mehta, Founder & Director of PHARMA-STATS has more than 15 years of versatile experience as a biostatistician in Bioequivalence studies, Clinical Trials, Dissolution similarity, IVIVC, Stability analysis, SAS programming, CDISC. PHARMA-STATS works with several pharmaceutical/CRO clients in India, USA & EU region. Biostatistical Services:  Sample size calculation, Statistical Inputs in Protocol & SAP development  Statistical SAS Programming, TFLs preparation  CDISC Migration for BE: Complete project submission  DSMB-Data Safety Monitoring Board Single Point Statistical Solution:  Statistical system implementation & Audit  SOP development  Support in regulatory query response  Review of failed BE study  CDISC development for BE: SAS Codes, SOPs, System setup Biostatistical Training to Pharmaceutical Industry:  Hands on training to understand fundamental of biostatistics on various areas: Bioequivalence, Clinical trials, Sample size, Study design, advance statistical design, outlier issues, formulation development, dissolution similarity, stability analysis, regulatory aspects  CDISC Training : Implementation, Regulatory Requirements & Applications in Bioequivalence Studies Biostatistical Training to Statisticians: The objective of this training is to build a community of qualified and dynamic statistical professionals by grooming young post graduates aspiring to create a mark in the domain.  Train fresher post-graduate-statisticians by self-designed industry oriented hands on training and their placements.  We have trained more than 100 fresher biostatisticians at PHARMA-STATS in last 4-years and completed their 100% successful placement in more than 50-companies across the India.